Registry for spontaneous intracranial hypotension and post-dural puncture headache
The Freiburg Registry on SpontanEous IntercrAnial Hypotension (SIH) & Post-duraL Puncture Headache (PDPH)
This study is collecting information from people with spinal fluid leaks to better understand the causes and symptoms of headaches related to spontaneous intracranial hypotension and post-dural puncture headache.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | University Hospital Freiburg Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Freiburg im Breisgau) |
| Trial ID | NCT06711731 on ClinicalTrials.gov |
What this trial studies
This registry aims to collect structured information on the frequency, causes, symptoms, and diagnostic procedures related to spinal cerebrospinal fluid (CSF) leaks, which can lead to chronic headache syndromes and other serious health issues. It focuses on two main conditions: spontaneous intracranial hypotension (SIH) and post-dural puncture headache (PDPH), both of which are often misdiagnosed. By gathering data from patients with suspected spinal CSF leaks, the registry seeks to improve awareness and understanding of these conditions, ultimately aiding in timely diagnosis and treatment. The study is observational and does not involve specific interventions.
Who should consider this trial
Good fit: Ideal candidates include patients with suspected spinal CSF leaks, characterized by new orthostatic symptoms or imaging suggestive of a leak.
Not a fit: Patients whose symptoms can be conclusively explained by another known diagnosis may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved diagnosis and treatment options for patients suffering from spinal CSF leaks.
How similar studies have performed: While there is increasing awareness of spinal CSF leaks, this registry represents a novel approach to systematically collect data on these conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with suspected spinal CSF leak based on one of the following * History of new orthostatic symptomes with or without prior spinal procedure * Imaging suggestive for spinal CSF leak 2. Informed consent Exclusion Criteria: a) Symptoms beeing conclusively explained by another known diagnosis
Where this trial is running
Freiburg im Breisgau
- Medical Center - University of Freiburg, Germany — Freiburg im Breisgau, Germany (Recruiting)
Study contacts
- Study coordinator: Katharina Wolf, Dr. med.
- Email: katharina.wolf@uniklinik-freiburg.de
- Phone: +49 761 270-50010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.